Drug Interaction Study With Famotidine, Atazanavir, and Atazanavir/Ritonavir/Tenofovir

Phase 1

Completed

• Conditions: HIV Infections
• Interventions: Drug: Atazanavir+Ritonavir+Tenofovir; Drug: Atazanavir+Ritonavir+Tenofovir+Famotidine

• Registration Number: NCT00365339
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this clinical research study is to assess the pharmacokinetics of atazanavir, identifying one or more dosing regimens of atazanavir/ritonavir/tenofovir when dosed with famotidine results in atazanavir exposures similar to those when atazanavir/ritonavir/tenofovir 300/100/300 mg is dosed without famotidine in healthy subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Primary Completion: 2006-06
• Study Completion: 2006-06
• Study First Submitted: 2006-08-16
• Study First Submitted QC: 2006-08-16
• Study First Posted: 2006-08-17
• Status Verified: 2009-01
• Last Update Submitted: 2011-04-07
• Last Update Posted: 2011-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Healthy male and female subjects between the ages 18 to 50 years old with a BMI 18 to 32 kg/m2

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Atazanavir+Ritonavir+Tenofovir	-
B	Atazanavir+Ritonavir+Tenofovir+Famotidine	-
C	Atazanavir+Ritonavir+Tenofovir+Famotidine	-
D	Atazanavir+Ritonavir+Tenofovir+Famotidine	-
E	Atazanavir+Ritonavir+Tenofovir+Famotidine	-

Primary Outcome Measures

Name	Time	Method
Assess PK of ATV, identifying dosing regimens of ATV/RTV/TDF when dosed with FAM that result in ATV exposures similar to ATV/RTV/TDF 300/100/300 mg with and without FAM.

Secondary Outcome Measures

Name	Time	Method
Assess PK , safety, and tolerability of ATV/RTV/TDF with and without FAM.

Trial Locations

Locations (1)

Local Institution; 🇺🇸 Hamilton, New Jersey, United States